Kornimate/medical-research-clean huggingface dataset:
edoxaban compared to standard care after heart valve replacement using a catheter in patients with atrial fibrillation (envisage-tavi af)

Conditions: Atrial Fibrillation

Summary: when the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. this is called atrial fibrillation. atrial fibrillation goes along with blood clots that may cause mainly strokes and less often other diseases, such as a heart attack. some patients with atrial fibrillation have other heart disease, such as heart valves that may need to be replaced using catheters. often doctors give patients drugs that reduce those blood clots. these are either vitamin k antagonist (vka) or direct anticoagulants, such as edoxaban. in these patients, it is unclear which of the drugs is better for reducing stroke without increasing severe bleedings.

use of edoxaban in patients with atrial fibrillation (af) and indication to chronic oral anticoagulation (oac) after transcatheter aortic valve implantation (tavi) objective: * to assess the effect of edoxaban versus vitamin k antagonist (vka) on net adverse clinical events (nace), i.e., the composite of all-cause death, myocardial infarction (mi), ischemic stroke, systemic thromboembolism (see), valve thrombosis, and major bleeding (international society on thrombosis and haemostasis \[isth\] definition). * to assess the effect of edoxaban versus vka on major bleeding (isth definition).

Eligibility criteria:
inclusion criteria: * meets protocol-specified criteria for qualification and contraception * is willing and able to comply with any restrictions related food, drink and medications * voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures exclusion criteria: * has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters * has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. the safety or well-being of the participant or study staff 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding) 3. the analysis of results

Keywords: transcatheter aortic valve implantation -- tavi anticoagulation atrial fibrillation envisage-tavi-af
obesity and mindful eating in patients with anxiety

Conditions: Anxiety; Obesity; Eating Behavior; Mindfulness; Inflammation; Self-Control

Summary: background: obesity is chronic disease with high prevalence rates, functional disability and difficult long-term management. anxiety is one of the most common psychological disorders in obesity, and when associated with other factors such as emotional eating and emotional dysregulation, it impairs treatment and interferes with lifestyle changes. finding an intervention that improves the eating behavior of these patients and facilitates adherence to obesity treatment, associated with less emotional distress, is of great clinical interest. objective: the aim of this study is to evaluate the effectiveness of the mindful eating (me) intervention on neurocognitive and behavioral outcomes in patients with obesity and anxiety compared to the control group with exposure to videos promoting quality of life. methods: a five-weeks randomized clinical trial will be performed with 52 patients in adulthood. the mindful eating intervention group will receive an online protocol with one meeting per week. this is a protocol that has been adapted for five weeks and consists of a group intervention with 10-15 participants. mindfulness, mindful eating and self-compassion training will be based on the eat for life protocol. the control group will receive five videos of psychoeducation, one topic per week. after, all participants will receive lifestyle advices, a first-line "treatment-as-usual" to obesity. there will be a face-to-face assessment with anthropometric, behavioral and biological measurements pre and post-intervention. the outcomes may help in understanding the mechanisms underlying the change in eating behavior, in order to direct new therapeutic strategies for the treatment of anxiety and obesity comorbidities.

this study is the second phase of a cross-sectional study.

Eligibility criteria:
inclusion criteria: * be between 18 and 50 years old; * inclusion for generalized anxiety disorder (gad): primary gad diagnosed by the m.i.n.i.; ✔inclusion for obesity: obesity bmi grade i (between 30.0 and 34.9); obesity bmi grade ii (between 35.0 and 39.9) exclusion criteria: * in individuals with obesity or control only, not having any psychiatric disorder; * in individuals with only gad or control, do not have a bmi above 25. * in individuals with gad, not having a diagnosis of primary or severe depression; * being under psychopharmacological, psychotherapeutic or nutritional treatment; * bipolar disorder, psychotic disorder, substance use disorder (except tobacco) in the last 6 months or suicidal ideation in the last 6 months (m.i.n.i); * have a clinical instability or immobility; * being in pregnancy or lactation; * antisocial personality disorder; * eating disorder.

Keywords: anxiety obesity eating behavior mindfulness
fat grafting used for the treatment of breast cancer related lymphedema in china

Conditions: Breast Cancer Lymphedema

Summary: breast cancer related lymphedema (brcl) is a common complication following breast cancer treatment. the incidence of brcl ranges from 6-50%, depending on the surgical procedure in the axilla and the type of the radiation therapy. brcl can causes cosmetic deformities, impaired physical mobility, mental discomfort, reduced quality of life and erysipelas. therapy of brcl is divided into conservative and operative methods. however, all the above method has some shortcomings. it is urgent to investigate new approaches to treat brcl. in this study, fat grafting is to be used for the treatment of brcl, and the efficacy and safety of this method will be also assessed.


Eligibility criteria:
inclusion criteria: breast cancer diagnosis regardless of the date of operation and identified unilateral arm lymphedema stage ⅱ of lymphedema according to the standard of international society of lymphology the patient is able to read, understand, and complete questionnaires. completed radiotherapy and/or chemotherapy at least 2 months prior to inclusion the patient understands the nature and purpose of this study and the study procedures and has signed informed consent. exclusion criteria: relapse of breast cancer untreated infection untreated heart failure untreated renal failure untreated deep venous thrombosis in the arm iodine allergy pregnancy psychiatric disorders

Keywords: fat grafting, breast cancer lymphedema
chemo-immunotherapy (gemcitabine, interferon-alpha 2b and p53 slp) in patients with platinum-resistant ovarian cancer

Conditions: Recurrent Ovarian Cancer

Summary: this study investigates the feasibility and immunogenicity of the triple combination of gemcitabine, peg-intron and p53 slp vaccination in patients with platinum-resistant ovarian cancer.

recurrent ovarian cancer has a dismal prognosis and there is a pressing need to identify more efficient therapies. ovarian cancer is highly immunogenic and good survival is tightly linked to the presence of tumor-infiltrating t cells and the absence of immunosuppressive immune cells. this anti-tumor immune response might be primed by chemotherapy. gemcitabine has immune-modulatory properties in addition to its direct cytotoxic effect in platinum resistant ovarian cancer. additionally, peg-intron allows the full maturation of dendritic cells, thereby enhancing the anti-tumor response. moreover, the tumor-associated self-antigen p53 is commonly over-expressed in ovarian cancer and can serve as a target for immunotherapy. therefore, chemo-immunotherapy with gemcitabine and peg-intron plus/minus p53 slp vaccination seems an attractive treatment for recurrent, p53+ ovarian cancer patients.

Eligibility criteria:
inclusion criteria: * histological proven epithelial ovarian cancer, peritoneal cavity or fallopian tube cancer (inclusive mucinous or clear cell tumors) * tumor over-expressing p53 * progression of disease or relapse after previous therapy with platinum * measurable disease (recist 1.1) or elevated ca125 \> 2 times the upper limit of normal within 3 months and confirmed * age ≥ 18 years * who performance status 0-2 * adequate bone marrow function: wbc ≥ 3.0 x 109/l, neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l * adequate liver function: bilirubin ≤ 1.5 x upper limit of normal (unl) range, alat and/or asat ≤ 2.5 x unl, alkaline phosphatase ≤5 x unl * adequate renal function: the calculated creatinine clearance should be ≥ 50 ml/min * survival expectation \> 3 months * patients must be accessible for treatment and follow-up * written informed consent according to the local ethics committee requirements exclusion criteria: * previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. * serious other diseases as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias * known hypersensitivity reaction to any of the components of the treatment * pregnancy or lactating * medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

Keywords: p53 overexpression platinum-resistant
the effect of locally delivered ciclosporin as an adjunct to healing after treatment of periodontal pockets

Conditions: Periodontitis

Summary: the main purpose of the trial is to investigate the effect of locally delivered ciclosporin as an adjunct to non-surgical mechanical debridement in the treatment of chronic periodontitis and to compare it to mechanical debridement alone.


Eligibility criteria:
inclusion criteria: * patients in good general health * 2 pairs of contralateral interproximal periodontal sites with probing depths of ≥7mm in single-rooted teeth not associated with furcations or root furrows.the test sites should have a distance of at least two teeth to the control sites. * teeth selected should have a vital pulp as determined by thermal or electric stimulation exclusion criteria: * patients already included in other clinical trials involving therapeutic intervention (either medical or dental) * periodontal treatment during the last 6 months * antibiotic treatment 6 months prior to the start of the trial * antibiotic prophylaxis required for dental treatment * patients with acute infectious lesions in the areas of intended treatment * regular anti-inflammatory medication * known history of ciclosporin allergy * ongoing medication that may affect the clinical features of periodontitis * patients who are smokers * patients that are immuno-compromized or on immunosuppressive medication * patients who are pregnant or lactating
a study of use of ella®, an emergency contraceptive, under simulated otc conditions

Conditions: Emergency Contraception

Summary: this study is designed to assess whether consumers select and use ella® (ulipristal acetate 30mg), an emergency contraceptive, in a manner consistent with the otc package directions in an otc-like setting.

all potential subject coming to a site looking to purchase ec will be offered to participate in the study. subjects who meet the initial screening inclusion criteria for the study will review package information and make a self-selection and purchase decision. subjects who meet all remaining inclusion criteria will purchase ella®, and use based on their understanding of the package information. follow-up data regarding product use and adverse events will be obtained during telephone interviews at approximately week-2 and week-6 after the date the subject was dispensed study product.

Eligibility criteria:
inclusion criteria: * women who are self-pay or who are willing to be self-pay for the purposes of the study and who present for emergency contraception only for their own use exclusion criteria: * cannot read, speak and understand english * cannot see well enough to read information on the label

Keywords: emergency contraception
evaluation of the effect of the perfecta v-beam laser on rosacea

Conditions: Rosacea

Summary: the purpose of this study is to further quantify the safety and effectiveness of the syneron-candela long pulse-duration, extended sub-pulse, larger spot-size prototype perfecta v-beam, 595nm laser system for the treatment of facial redness associated with flushing and blushing, or rosacea. the perfecta laser system is expected to provide effective treatment of rosacea with less bruising or purpura and greater effectiveness than previous generation systems. this study should enable optimization of treatment parameters for using the perfecta 595nm laser for treating rosacea.


Eligibility criteria:
inclusion criteria: * subjects must have a fitzpatrick skin type of i-iv and have rosacea as evaluated by the treating physician. * subjects must have visible telangiectasia on the side of the face. * subjects must be willing and able to comply with all follow-up requirements. * subjects must be willing and able to apply sunblock spf of 30 while exposed to the sun. * subject willing to have photographs taken and used in presentations or publications. exclusion criteria: * subjects must not have had a previous laser treatment, deep chemical peel in the intended treatment site(s) within 6 months prior to treatment, oral retinoids within 6 months of their inclusion into this study or have ever taken gold therapy. * subjects must not have a history of keloid formation. * subjects with fitzpatrick classification of v or vi (to reduce the risk of hyper-pigmentation). * subjects must be willing and able to comply with all follow-up requirements. * subjects cannot have vitiligo, a condition where pigment is lost in the skin and white patches appear). * subjects not willing to avoid sun exposure or not will to apply sunblock spf of 30 while exposed to the sun. * subject not willing to have photographs taken and used in presentations, publications and marketing material
the role of pre-natal ultrasound in predicting outcomes of fetal ovarian cysts

Conditions: Fetal Ovarian Cyst

Summary: the goal of this observational study is to investigate whether there are any prenatal ultrasound features that may predict the need for postnatal surgery versus spontaneous regression of such formations, so that better counseling can be provided to parents even in the prenatal period.

the rationale of the study is to define the role of prenatal ultrasonography in diagnostic framing and prognostic guidance in cases of suspected fetal ovarian cyst detection. prenatal ultrasonography in such cases detects the presence of a pelvic formation in female fetuses, although the differential diagnosis is not always straightforward and can only be placed with certainty in the postnatal period. the investigators will therefore retrospectively assess postnatal outcomes in newborns prenatally diagnosed with ovarian cysts and investigate the presence of any prenatal ultrasound findings most associated with an unfavorable postnatal prognosis in terms of need for surgery and fetal complications. this will allow the investigators to more precisely delineate the timing of serious prenatal ultrasound checks once the diagnosis of fetal ovarian cyst is established. ultrasound follow-up has been performed in all infants with prenatal ultrasound suspicion of ovarian cyst and continues until the cyst disappears, which occurs on average within the first six to 12 months of life. follow-up therefore is generally 12 months, but may be discontinued early in case of earlier resolution of the cyst.

Eligibility criteria:
inclusion criteria: * single pregnancy * age greater than or equal to 18 years * detection of suspected fetal ovarian cyst on ultrasonography * performance of delivery at the division of obstetrics and prenatal age medicine exclusion criteria: none

Keywords: ultrasound
early renal replacement therapy in covid 19 patients with aki does it improve the outcome?

Conditions: Multi Organ Failure

Summary: patients will be divided into two equal groups, each group including 50 adult patients with a confirmed diagnosis of covid, patients with acute kidney injury, the first group will be treated with early hemodialysis, second group will be conservative until there is an urgent need for dialysis


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years old) with confirmed severe acute respiratory syndrome coronavirus 2 infections admitted to the icu. exclusion criteria: * •malignancy. * immuno-deficiency diseases. * chronic diabetic, cardiac and hypertensive patients * autoimmune diseases.
evaluation of clinical and functional results after operative correction of lesser toe deformities

Conditions: Plantar Plate Tear; Metatarsalgia; Lesser Metatarsophalangeal Joint Instability; Hammer Toe; Surgery; Plantar Plate Repair

Summary: the plantar plate is an important static stabilizer of lesser metatarsophalangeal joints, and disruptions of the plantar plate can lead to significant instability and lesser toe deformities.our study proposes an inexpensive and versatile method for plantar plate repair

a torn plantar plate is small and difficult to access using regular instruments in a restricted operative field. a unique method for plantar plate repairs was used to repair various configurations of plantar plate tears with standard operative instruments that is available in most operating rooms. a retrospective study was performed on patients who underwent operations for lesser mtpj instability between september 2015 and december 2019. the outcome analysis included the lesser metatarsophalangeal-interphalangeal scale from the american orthopedic foot and ankle society (aofas) forefoot score, the visual analogue scale score for pain and satisfaction, and answering the question "would you recommend this procedure to other patients?"

Eligibility criteria:
inclusion criteria: * clinical diagnosis of lesser metatarsophalangeal joint instability * clinical diagnosis of metatarsalgia * lesser metatarsophalangeal joint instability clinical grades of ii to iii, which were determined using the drawer test. exclusion criteria: * previous operatve treatment of the affected lesser metatarsophalangeal joint. * rheumatioid arthritis. * neurologic disorders (e.g., parkinsonism, charcot's neuroarthropathy...etc.). * postoperative follow-ups of less than 12 months
evaluating the infant complex congenital heart disease by multidetector computed tomography

Conditions: Heart Diseases

Summary: to test the ability of multi-detector spiral ct in evalting the infant complex congenital heart disease.

to test the ability of multi-detector spiral ct in evalting the infant complex congenital heart disease.

Eligibility criteria:
inclusion criteria: complex congenital heart disease exclusion criteria: -

Keywords: heart diseases congenital
effect of implementing evidence based practices on prevention of associated nasal pressure injuries among preterm neonates with non-invasive respiratory support

Conditions: Mechanical Ventilation Complication; Respiratory Distress Syndrome in Premature Infant

Summary: this study aims to evaluate the effect of implementing evidence based practices on prevention of associated nasal pressure injuries among preterm neonates with non invasive respiratory support

the researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the neonates provided an informed consent. over a one-week period, staff education programs regarding evidence-based guidelines for non-invasive respiratory support will be conducted for nicu nursing staff. these sessions, lasting 15 to 20 minutes, will be held during regularly scheduled work hours, with four different sessions will offer throughout the day. the preterm neonates' characteristics and clinical data will be extracted from their hospital records for the two groups on the first day of admission for both groups prior to intervention to identify those who fulfilled the current study's inclusion criteria. neonatal baseline data was collected from their records on the first day of admission for the two groups prior to intervention in order to identify neonates who meet the required criteria of the study. then the participants were selected and divided randomly (using a simple random method) into two equal groups. one subject for the control group, one for the study group and so on, distributed the participants into two equivalent groups as fellow: control group: consisted of 30 premature neonates who will receive conventional hospital care with no additional interventions. study group: consisted of 30 premature neonates who will receive 6 evidence-based practices on the prevention of nasal pressure injuries as follows: * use an appropriately sized nasal interface device. * the use of skin barrier products between nasal skin and nasal interface device * visually examining the preterm newborn every hour to ensure appropriate nasal interface position * once every 12-hour shift, the protective barrier and nasal device are briefly removed to allow for a full nasal skin examination * follow developmental care principles by repositioning the infant every three to four hours. * pain scores should be taken at least every three to four hours.

Eligibility criteria:
inclusion criteria: * preterm neonates receiving nirs * whose gestational ages ranges between 30 and 37 weeks, and both genders exclusion criteria: * all preterm neonates not receiving nirs, * have prior nasal trauma caused by tracheal intubation * or infants exhibiting evidence of nasal damage during the nirs procedure, * have upper respiratory abnormalities. * preterm neonates who have undergone any type of surgery and had life-threatening congenital abnormalities.
glyceryl-trinitrate-induced headache in patients with familial hemiplegic migraine type 1 and 2

Conditions: Familial Hemiplegic Migraine Type 1 and 2; Healthy Volunteers

Summary: the aim of the present study is to explore functional consequences of migraine gene mutations on their responses to gtn infusion.

glyceryl trinitrate (gtn) induces migraine attacks indistinguishable from spontaneous attacks in approximately 80% of migraine sufferers. after systemic administration gtn is transformed to nitric oxide (no). treatment of spontaneous migraine attacks with an inhibitor of no is effective in 60% of patients. these data show that no is involved in both initiation and maintenance of migraine attack. the consequence of migraine gene mutations on relevant migraine pathways has never been tested. the aim of the present study is to explore functional consequences of migraine gene mutations on their responses to gtn infusion. the project will improve our understanding of the neurobiology of migraine and stimulate development of new treatment targets.

Eligibility criteria:
inclusion criteria: patients: diagnosis of familial hemiplegic migraine (ihs-classification criteria) caused by mutations in the cacna1a gene and the atp1a2 gene. controls: healthy volunteers exclusion criteria: controls: no primary headache in their own history patients and controls: * a history of cerebrovascular disease and other cns- disease * a history of serious somatic and mental disease * a history suggesting ischaemic heart disease * a history of hypo- or hypertension * daily intake of medication apart from oral contraceptives * abuse of alcohol or medicine (opioid analgesics). * pregnant or breastfeeding women. on the study day: * no intake of a simple analgesic in the previous 48 hours * no headache in the previous 48 hours

Keywords: familial hemiplegic migraine type 1 and 2 gtn middle cerebral artery superficial temporal artery headache genotype